Status:
COMPLETED
Interchangeability of Infanrix™ IPV/Hib and Pediacel® at 2,4 & 6 Months of Age
Lead Sponsor:
Dalhousie University
Collaborating Sponsors:
IWK Health Centre
MCM Vaccines B.V.
Conditions:
Infant Immunizations
Eligibility:
All Genders
42-3 years
Phase:
PHASE3
Brief Summary
To demonstrate the safety and immunogenicity of two mixed primary immunization schedules: Pediacel® at 2 and 4 months of age followed by one dose of Infanrix™ IPV/Hib at 6 months of age; and, Infanrix...
Detailed Description
Immunogenicity will be evaluated using the following: Serological outcome measures will be assessed on day 0 (visit 1) and 28-42 days after the 3rd dose of the primary series for both groups: * Sero...
Eligibility Criteria
Inclusion
- Infants aged 6 wks (42 days) to 2 months (1 day before they turn 3 months) inclusive on the day of inclusion.
- Born at full term of pregnancy (defined as ≥37 weeks, 0 days).
- Informed consent form signed by the parent(s) or legally authorized representative.
- Able to attend all scheduled visits and to comply with the study procedures.
- Parent or legally authorized representative has access to a telephone.
- Parent or legally authorized representative able to read and write in English or French.
Exclusion
- Participation in another clinical trial in the 4 weeks preceding the first trial vaccination.
- Planned participation in another clinical trial during the present trial period.
- Personal history of congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy.
- Known or suspected systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances as the trial vaccine(s).
- Chronic illness that could interfere with trial conduct or completion.
- Received blood or blood-derived products since birth.
- Any vaccination preceding the first trial vaccination, except vaccinations recommended as part of the infant schedule.
- Previous vaccination with any acellular pertussis- (DTaP) or whole cell pertussis-DTwP) based combination vaccines, Haemophilus influenzae type b Hib)conjugate,or poliovirus vaccines.
- Coagulation disorder contraindicating intramuscular vaccination.
- Clinically significant findings on review of systems (determined by investigator or sub-investigator to be sufficient for exclusion).
- Developmental delay or neurological disorder.
- Any condition which, in the opinion of the investigator, would interfere with the evaluation of the vaccine or pose a health risk to the subject.
- History of Hib, diphtheria, tetanus, pertussis or poliovirus disease.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
253 Patients enrolled
Trial Details
Trial ID
NCT00990080
Start Date
May 1 2010
End Date
January 1 2011
Last Update
June 15 2011
Active Locations (2)
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1
Canadian Center for Vaccinology
Halifax, Nova Scotia, Canada, B3K 6R8
2
MUHC- Vaccine Study Centre
Pierrefonds, Quebec, Canada, H9H 4Y6